FDA.report

Mack's

Primary DI
00033732000079
Brand
Mack's
Company
McKeon Products, Inc.
Model
Pillow Soft Silicone Putty Earplugs
Catalog number
7
Device description
Moldable Silicone Earplugs - 6 Pair Value Pack
Published
2022-10-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
EWDProtector, Hearing (Insert)

Product Code Classifications

CodeDeviceSpecialtyClass
EWDProtector, Hearing (Insert)UnknownU

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00033732000079PrimaryGS10
10033732000076Unit of UseGS10

GMDN Terms

TermDefinition
Earplugs, reusableA device, usually used as a pair, made of rubber or pliable plastic/silicone material intended to be inserted into the outer ear canal for protection against excessive noise levels or water entering the ears when swimming/bathing. This device may be premoulded (preformed) or mouldable. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
006522122
Device count
12
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00033732100786Mack'sPillow Soft Silicone Putty Earplugs7T2025-08-05
00033732107129Mack'sPillow Soft Silicone Putty Earplugs7122025-08-05
00033732107181Mack'sPillow Soft Silicone Putty Earplugs7182025-08-05
10033732000052Mack'sPillow Soft Silicone Putty Earplugs52022-10-07
10033732000069Mack'sPillow Soft Silicone Putty Earplugs (Orange)62022-10-07
10033732000083Mack'sPillow Soft Silicone Putty Earplugs (Beige)82022-10-07
10033732000106Mack'sKids Size Soft Moldable Silicone Putty Earplugs102022-10-07
10033732002001Mack'sPillow Soft Silicone Putty Earplug Dispenser2002022-10-07
10033732002063Mack'sPillow Soft Silicone Putty Earplug Dispenser (Oran2062022-10-07
10033732002087Mack'sPillow Soft Silicone Putty Earplug Dispenser (Beig2082022-10-07
10033732002100Mack'sKids Size Moldable Silicone Putty Earplug Dispense2102022-10-07
10033732010150Mack'sKids Size Soft Moldable Silicone Putty Earplugs10152022-10-07
00033732010306LunaGuardNighttime Dental Guard10302022-10-07
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00033732023023AirmaxNasal Dilator - Small - Clear23022022-10-07
00033732023252AirmaxNasal Dilator Trial Pack (1 small + 1 medium)25252022-10-07
00033732023498AirmaxNasal Dilator - Medium - Orange23492022-10-07
00033732023504AirmaxNasal Dilator - Medium - Clear23502022-10-07

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